FDA Commissioner Scott Gottlieb, MD, on Tuesday announced a series of guidance documents aimed at expanding the availability of biosimilar drugs, specifically by targeting what he called “anti-competitive practices” that abuse current regulations and distribution systems.
In a draft Q&A guidance released Tuesday, the FDA called out companies that use — and, according to Gottlieb, sometimes abuse — limited distribution systems, at times in connection with Risk Evaluation and Mitigation Strategy (REMS) programs, to block access to reference product samples, which are necessary for biosimilar developers to run tests.
“While the limited distribution programs can have a role in promoting patient safety, too many branded products are still misusing these programs as rhetorical smokescreens to hide anti-competitive behavior,” Gottlieb said in a statement released by the FDA. “We’re not going to be partners to these deceptions.”
The FDA commissioner on Tuesday announced a series of guidance documents aimed at expanding the availability of biosimilar drugs by targeting practices that abuse current regulations and distribution systems.
According to Gottlieb, just as the FDA has publicly identified cases where generic sponsors have experienced difficulty in accessing reference drug doses, so too will officials focus attention to “these same potentially anti-competitive practices when it comes to biosimilar drugs.”
To that end, the commissioner noted that the FDA will now, upon request, review study protocols submitted by biosimilar applicants to assess whether their protocols contain comparable safety protections to those in the REMS for the reference product they want to access.
If requested, the FDA will issue a letter to the to the holder of the reference product informing them that comparable protections exist, and that the FDA will not consider it to be a violation of the branded drug company’s REMS to provide the biosimilar sponsor with a sufficient quantity of the reference product to perform necessary testing in support of their application.
“This is just a start,” Gottlieb said in the statement. “We’re going to be monitoring these markets. And we’ll be taking additional actions. We’re actively evaluating how we can make it easier for biosimilar manufacturers to use reference products from outside the U.S., where prices may be cheaper and reference products more accessible.”
According to the commissioner, the FDA will issue a total of two guidance documents providing “greater clarity on scientific and regulatory considerations” for biosimilar and interchangeable product development. He added that the FDA intends to update these documents regularly to address any developments that may arise.
In July, the FDA announced a Biosimilar Action Plan, which aimed to expand biosimilar competition by improving the efficiency of the biosimilar and interchangeable product development and approval process. Other aims of the program include maximizing scientific and regulatory clarity, and stopping attempts to unfairly delay market competition for follow-on products.
The FDA in 2018 approved a record seven biosimilar products, bringing the total of approved biosimilars to 15. However, only three biosimilars are currently on the market in the United States, chiefly due to litigation slowing down the process and widespread consolidation across the drug supply chain, with manufacturers, pharmacy benefit managers, group purchasing organizations and distributors splitting monopoly profits, according to Gottlieb.
“I know a lot of these drugs never launched owing to patent issues,” he said in the statement. “Like the early days of [the] Hatch-Waxman [Act], there are legal issues that are being worked out related to the patents governing these products, and the kinds of deals that companies strike with each other. This is a dynamic market, and we’ll continue to address potential barriers to competition as they emerge, including in partnership with colleagues at the Federal Trade Commission.” – by Jason Laday